Package for sterilized articles



A ril 21, 1970 ICHiRO lSHll ETAL v 3 507 335 PACKAGE FOR STERILIZEDARTICLES Filed Sept. 10, 1968 United States Patent 3,507,386 PACKAGE FORSTERILIZED ARTICLES Ichiro Ishii and Yasuo Kajihara, Tokyo, Japan,assignors to Jintan Terumo (30., Ltd., Tokyo, Japan, a corporation ofJapan Filed Sept. 10, 1968, Ser. No. 758,922 Int. Cl. A61b 19/02 US. Cl.206--63.2 6 Claims ABSTRACT OF THE DISCLOSURE A package for sterilizedarticles comprising receptacle made of gas-impermeable film forenclosing the articles, and gas-permeable germproof paper constituting asmall passage inside the receptacle, through which sterile gas can bepenetrated to sterilize articles contained Within the package.

The present invention relates to a package for sterilized articles whichis not only suited for use in gas sterilization of medical implementsand materials such as a syringe, gauze, etc. which must be clean andfree from any kind of germs before use, but also capable of preservingsuch articles in their fully sterilized condition over a long period oftime after sterilizing treatment.

Heretofore, this type of package has consisted of transparent plasticsfilm for easy observation of the contents. However, since plastics havepoor heat resistance, they present difficulties in thermalsterilization. Accordingly, it has been required to disinfect medicalarticles in advance and seal them up under a well sterilized condition.However, such sterilizing and packaging processes involve considerablecomplications and are also undesirable from the standpoint of operatingefficiency.

Therefore as a means to eliminate the aforementioned drawbacks, one ofthe known methods proposed to date consists in preparing a package froma gas-impermeable film made, for example, of plastics, perforating aplurality of through apertures of a desired size at several appropriatepoints on the side of the package, bonding thereon, for example, a sheetof paper which has gaspermeability and yet does not permit thepenetration of bacteria, so as to close up the aforesaid apertures, anddisinfecting packaged articles by placing the package in an atmosphereof sterilizing gas such as ethylene oxide.

While such package may indeed be useful in disinfect ing enclosedarticles with a sterilizing gas, the gas-permeable germproof paperavailable to this end has poor water repellency and is very vulnerableto water and moisture. Accordingly, it can not avoid encountering agreat many inconveniences or difficulties. For example, where such kindof paper absorbed water or moisture, it naturally tended to be peeledoff from its place, damaged or broken. As a result, elaboratelydisinfected articles were most likely contaminated and, unlesssterilized again, could not be used safely soon after being taken out ofthe package, particularly under unfavorable conditions prevailing inareas such as those affected by natural calamities or other causes.

To make up for such shortcomings, it might be contemplated to reduce theaforementioned apertures to an extremely small size or to cover the partof the package, on which is superposed the germproof paper, withgasimpermeable film. However, this would have an undesirable effect, forexample, of obstructing the introduction of sterilizing gases, consuminga great deal of time in completing sterilization, or presentingconsiderable difficulties in properly closing up the rugged side of thepackage after sterilization of enclosed articles.

3,507,386 Patented Apr. 21, 1970 The present invention has beenaccomplished with the view of providing a package for sterilizedarticles wherein efiicient sterilization can be carried out usingsterilizing gases and, if required, the paper tape enclosed thereinthrough which is sterilizing gas is allowed to permeate can be veryeasily rendered fully waterproof, thereby to preserve the packagedarticles of their well sterilized condition over a long period of time.The invention is characterized in that along the inner wall of onelengthwise end portion of a package made of heat-scalable film is formeda tubular tape of gas-permeable germproof paper extending from onecrosswise end to the other crosswise end of the package and open to theoutside thereof at one end or both ends, sterilizing gas introduced intothe tubular paper tape is allowed to penetrate the paper Walls into thepackage, and if required, both open ends of the tubular tape are sealedwater-tight after sterilization.

In the drawing:

FIG. 1 is a plan view of a package according to an embodiment of thepresent invention where a syringe is enclosed;

FIG. 2 is a sectional view on line II-II of FIG. 1;

FIG. 3 is a sectional view on line III-III of FIG. 1; and

FIGS. 4 and 5 jointly represent a plan view, with a part broken away, ofa package according to another embodiment of the invention, showing theprocess of packaging an article for sterilization.

There will now be described the present invention with reference to theillustrated embodiments.

Numeral 11 in the drawing represents a package consisting of transparentgas-impermeable heat-sealable film. The package is prepared by foldingin two a piece of such film cut in a rectangular form and heat sealingthe superposed open edges 13, 14 and 15, and is intended to enclose anarticle to be sterilized, for example, a syringe as shown in FIG. 1. Inthe lengthwise direction of the package along the inside of the sealededge 14 is formed a tape 16 of gas-permeable germproof paper folded intwo which extends from one cross-wise end 13 to the other crosswise end15. The germproof paper tape is arranged in such a manner that itsfolded side faces the interior of the package. Further, tape, except forthe folded part and its vicinity, is heat sealed to the inner walls ofthe package. The term gas-permeable germproof paper, as used in thepresent invention, means that type of paper which is gas-permeable at ahigher gas pressure than the atmospheric but little gas-permeable at anatmospheric pressure, so that it has a property of preventing thepenetration of bacteria under normal conditions. The concrete examplesof such paper include kraft paper and the like.

Especially those consisting of long filaments, and having goodpermeability and smooth surface are preferable. Concerning the thicknessof the gas-permeable paper, it should neither be too thin to hinder thepassage of germ therethrough, nor too thick to create a gap likely to beformed between the gas-impermeable film and the crease of the paperheat-sealed to the film. Generally a thickness in the range of 30 tomicrons to be appropriate.

The paper can be easily heat-sealed to heat-scalable film such asplastics film but not to each other. Consequently, when the superposedcrosswise ends 13 and 15 of the package 11 are heat-sealed, the oppositefilms of the folded paper tape 16 are not mutually heat-sealed, butremain separated as shown in FIG. 2 thereby to form a tubular hollowspace or aperture 17 extending from one crosswise end 13 to the othercrosswise end 15. Thus the inside and outside of the package 11communicate with each other through said aperture 17.

When the package 11 constructed in the aforementioned manner is placedin a vessel filled with sterilizing gas, the gas is introduced from bothopen ends of the tubular aperture 17. Then as shown in FIG. 3, the gaspenetrates the wall of that part 16a of the paper tape 16 which is notsealed to the inner walls of the package, namely, the folded sectionthereof, and is carried into the package thereby to sterilize a syringe12 placed therein. In this case, the non-sealed part 16a of the papertape 16 through which the sterilizing gas permeated has a broad area,and permits very effective sterilization. The interior of thesterilizing gas vessel is kept at a higher pressure than the atmosphericwith sterilizing gas introduced under pressure, so that the gas caneasily penetrate the gaspermeable walls of the paper tape 16.

In the package of the present invention, the gas-permeable paper issurrounded by gas-impermeable plastic sheeting, so that there is littledanger of the paper relatively weak to water and moisture being damagedor broken due to an external cause, so that, once sterilized, a packedarticle can be preserved of its sterilized condition over a long periodof time. Consequently the paper can well serve ordinary uses as it is.However, for better protection of the paper from water and moisture, itis advisable to attach, as shown in FIG. 4, a small heatsealable tab 18made of the same material as the package 11 to the vicinity of the openends of the tubular aperture of the paper tape 16, and after sterilizingof a packaged article, fold it in the direction of the arrow a and heatseal said opening. Then the opening can be fully sealed up as shown inFIG. 5, completely preventing the intrusion of water and moisture orbacteria through a medium of water into the interior of the package.Such arrangement could keep packaged articles fully sterilized evenunder extremely unfavorable conditions most likely exposed to heavyrainfalls or storms in particular, for example, in such environments asprevailing in affected areas.

The width of the non-sealed part 16a on the folded side of the papertape 16 may be suitably selected taking into account the gaspermeability of paper material and the conditions for sterilization. Forexample, when the width of the non-sealed part 16a is too narrow, thepassage of sterile gas becomes difficult, and when it is too wide, thepossibility of a packed article being contaminated by germs willconsiderably increase and the article may not be assured of its sterilecondition.

One of the preferred example is as follows: Gas-permeable paper 16,having a width of 16 mm. is folded in two and fixed as shown in FIG. 1to the inside of package 11, 50 mm. x 195 mm. in size, leavingnon-sealed zone of about 8 mm. This package 11 is evacuated to removethe air filled therein taking about 20 minutes, and is sterilized in theatmosphere comprising 20 volume percent of ethylene oxide and 80 volumepercent of carbon dioxide and having the humidity of 60-80%, at thetemperature of 50-60" C., and at the pressure of 2.3-2.5 kg./cm.(absolute pressure) taking hours. Thus treated package proves to bemaintainable of its sterilized condition over a long period of time. Theair permeability of the paper employed in the above example is such thatit takes 23 seconds to pass 100 ml. of air through the area of 645.16mm. of the paper under the pressure of 87.9 g./cm.

A sterilized article can be easily taken out simply by tearing open thepackage at a suitable part. However, to ease the tearing, the packagemay be provided in advance with a notch 19 at an appropriate part asshown in FIG. 1. The aforesaid embodiments relate to the case where thepaper used for the permeation of sterilizing gas was folded in two andfitted to the inside of the package. However, the present invention isnot limited thereto, but allows the use of gas-permeable germproof paperwhich has been fabricated in advance into a tubular form having at leastone of its ends open to the outside of the package as in the precedingcase.

As mentioned above, the sterilization package of the present inventioncontains a tape of gas-permeable germproof paper shaped into a tubularform which allows sterilizing gas to permeate through the walls thereof.Since the package has a broad area through which the sterilizing gas canpermeate, sterilizing efficiency is prominently increased. Further, theouter surface of the paper tape is protected with waterproof material toprevent the paper tape from being damaged or broken due to absorption ofwater or moisture, thus eliminating the danger of the packaged articlebeing contaminated with. bacteria. Moreover, the tubular paper tape hasan extremely small aperture open at the edge of the package throughwhich the sterilizing gas is introduced, and is open to the outside ofthe package only at one end or both ends thereof. Therefore the sealingof the open ends of the paper tape can be easily carried out withoutbeing obstructed by an enclosed article. The package of the presentinvention also has the advantage that it can not only take the place ofa separate bag commonly used in sterilizing an article, but also, aftersterilization, be used as an ordinary sterilization package as it is orby sealing both ends of the paper tape. Further, if the gas-permeablepaper tape is colored in various shades to indicate the kinds of packagearticles, there will be obtained convenience in handling.

The foregoing embodiments were associated with a package prepared byfolding a gas-impermeable film in two. But the present invention is notlimited thereto, but permits the use of a rectangular bag sealed inadvance on three sides. In this case, a tape of gas-permeable paper maybe bonded along the remaining open side by heatsealing as describedabove or other similar means so as to form a tubular aperture. The openside is tightly sealed after the enclosed article is completelysterilized.

The sterilizing package of the present invention is most suited indisinfecting and preserving medical implements such as a syringe, bloodtransfusion set, petri disk, rubber gloves, etc. or auxiliary medicalconsumables such as gauze, absorbent cotton, bandage, suturing threads,etc.

What is claimed is:

1. A package for sterilized articles comprising a receptacle formed ofgas-impermeable film for enclosing an article to be sterilized, saidreceptacle having a first longitudinal edge therein which ishermetically heat-sealed, a tubular member formed of gas-permeable,bacteria-impermeable paper having at least one end thereof extendingthrough said first edge, the interior of said tubular member being openthrough said end to the outside of said receptacle, the outer surface ofsaid end being hermetically sealed to said rfirst edge, the interior ofsaid tubular member being sealed off from direct communication withinterior of said receptacle.

2. A package as claimed in claim 1 wherein said receptacle has a secondlongitudinal edge intersecting said first edge and a third longitudinaledge intersecting said second edge, said tubular member being positionedadjacent said second edge and extending through said third edge with theouter surface of the end of the tubular member extending through saidthird edge being hermetically sealed to said third edge.

3. A package as claimed in claim 1 wherein the package includes asealable tab that if foldable over said one end of the tubular memberfor hermetical sealing of said one end.

4. A package as claimed in claim 3 containing a sterilized article, saidone end of said tubular member being hermetically sealed by said tab.

5. A package as claimed in claim 1 wherein said tubular member is formedof kraft paper having a thickness between about 30 to microns.

6. A package as claimed in claim 1 wherein said tubular member is formedof paper tape folded back upon 5 6 itself and the overlapping edges ofthe tape are sealed 2,883,262 4/1959 Borin 206-43 within a longitudinaledge in said receptacle. 2,947,415 8/1960 Garth 20663.2 3,092,249 6/1963 Chapman 20646 References Cited 3,084,793 4/1963 Pitrnan 20663.23,229,813 1/1966 Crowe et a1 229-53 UNITED STATES PATENTS 5 3,073,5071/1963 Trewella et a1. 229-62 1,798,406 3/1931 Dunn 229-15 2,433,05612/1947 Masci 206-632 WILLIAM T, DIXSON, JR. Primary Examiner

